Percutaneous Endoluminal Benign Biliary Laser

NCT05567003 | Terminated Phase 4

• 1 other identifier: 21-001910
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to evaluate the safety and efficacy of Percutaneous transhepatic cholangioscopic (PTCS) laser incision as an ancillary therapy to traditional approaches such as balloon dilation and large drain placement for Benign Biliary Strictures (BBS). Narrowing or blockage of the bile ducts (biliary stricture) is a difficult to treat medical condition that leads to life-threatening complications. Treatment usually involves multiple procedures or surgeries spanned over months or years, and in many cases, leads to the need for a life-long tube that drains bile fluid outside of the body and into a bag. PTCS laser incision is a promising new treatment for bile duct strictures. The procedure is performed by an Interventional Radiologist who uses a tiny camera (endoscope) and a laser through a small hole in the skin to open up the blocked or narrowed duct. This allows bile to flow freely where it is supposed to go (without a tube) so that it does not backup up and cause life-threatening problems. Based on early experience from patients who have had this procedure done, it appears to be safe and effective, and may lead to needing fewer procedures over time, with the possibility of living without a tube or drain. The main goal of this study is to confirm the safety and efficacy of PTCS laser incision in a series of patients with benign biliary strictures who would otherwise receive standard treatment with long-term biliary tube drainage.

Conditions

Benign Biliary Strictures With Current or Prior Biliary Obstruction

Outcome Measures

Primary Outcomes (2)

• Incidence of Post Procedure Adverse Events

  Safety evaluated by cumulative rates of post-interventional complications after PTCS-guided laser incision. 1. Complications will be reported according to the Society of Interventional Radiology Adverse Event (AE) classification system. 2. Safety will be reported as 30-day composite of all post-procedure AEs. 3. Complications will be further qualified and quantified by AE severity category and individual AE types.

  Up to 24 months

• Feasibility of Procedure

  Feasibility evaluated by technical success of PTCS-guided laser incision. a. Technical success defined as endoscopic and cholangiographic evidence of improved patency at the time of intervention.

  Up to 24 months

Secondary Outcomes (3)

• Primary Bile Duct Patency

  Up to 24 months

• Tube-Free Survival

  Up to 12 months

• 12-Month Cumulative Complications

  Up to 12 months

Study Arms (1)

Patients with benign biliary strictures

OTHER

Patients with benign biliary strictures with current or prior biliary obstruction, who would otherwise receive standard treatment with long-term biliary tube drainage.

Procedure: Percutaneous transhepatic cholangioscopic (PTCS) laser incision

Interventions

Percutaneous transhepatic cholangioscopic (PTCS) laser incision PROCEDURE

Infrared percutaneous transhepatic cholangioscopic guided holmium laser incision for treatment of benign biliary strictures.

Patients with benign biliary strictures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of Benign Biliary Strictures (BBS)
• Clinical and/or laboratory evidence of biliary obstruction (current or prior)
• Age 18 years or older at the time of intervention

You may not qualify if:

• Patients with a diagnosis of malignant biliary stricture at the time of enrollment
• Patients who are subsequently diagnosed with malignant biliary stricture during the study period
• Liver transplantation within the last 90 days
• Active cholangitis or sepsis
• Emergent need for biliary decompression
• Patients with a diagnosis of primary sclerosing cholangitis with presence of 3 or more strictured segments
• Patients with a life-expectancy of less than 36 months

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Study Officials

• Ravi N Srinivasa, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Vascular and Interventional Radiology

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 5, 2022
• Study Start: November 1, 2022
• Primary Completion: January 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)